Bedside Cranial Ultrasound for Risk-Stratified Imaging in Pediatric Acute Brain Injury

NCT07772323 | Not Yet Recruiting

• 1 other identifier: HM300000147
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Acute brain injury (ABI) is a leading cause of death and long-term disability in children. Diagnosis depends on fast neuroimaging, and head computed tomography (CT) is the bedside reference standard despite exposing the developing brain to ionizing radiation. A safe, portable, radiation-free bedside tool is needed to help decide which children need a head CT, to speed CT when injury is present, and to safely monitor injured children between scans. This study evaluates B-mode cranial point-of-care ultrasound (cPOCUS) performed through the temporal (and frontal) bone windows in children undergoing a clinically indicated head CT in the pediatric emergency department (ED) and pediatric intensive care unit (PICU). Children's thin skulls provide adequate acoustic windows in more than 95% of cases. cPOCUS is acquired by trained research scanners within 6 hours of head CT and interpreted offline by two blinded expert readers; the radiology CT report is the diagnostic gold standard. This is a prospective observational study; cPOCUS results are not returned to the clinical team in real time and do not change clinical care.

Conditions

Acute Brain Injury; Traumatic Brain Injury; Intracranial Hemorrhage; Hydrocephalus; Stroke; Brain Neoplasm; Hypoxia-Ischemia, Brain

Keywords

cranial ultrasound; point-of-care ultrasound; cPOCUS; transcranial B-mode ultrasound; pediatric neuroimaging; head CT; midline shift; diagnostic accuracy; radiation reduction; neurocritical care

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of cranial point-of-care ultrasound (cPOCUS) versus head CT

  Diagnostic accuracy of the adjudicated consensus cPOCUS read (index test) for a binary abnormal versus normal head CT (reference standard = attending radiology CT report), reported as sensitivity, specificity, positive predictive value, and negative predictive value, each with 95% confidence intervals, at the first paired CT-cPOCUS assessment. Abnormal scan is defined as presence of any new midline shift, hydrocephalus or parenchymal echogenicity.

  First paired CT-cPOCUS assessment (cPOCUS within 6 hours of head CT; Day 1)

Secondary Outcomes (8)

• Inter-reader reliability of cPOCUS interpretation

  First paired assessment; monitored quarterly through study completion (up to 24 months)

• Per-reader diagnostic accuracy and paired reader comparison

  First paired CT-cPOCUS assessment (Day 1)

• Etiology- and subgroup-specific diagnostic accuracy (descriptive)

  First paired CT-cPOCUS assessment (Day 1)

• Age and skull-thickness inflection point (upper age limit of utility)

  Through study completion (up to 24 months)

• Pediatric cPOCUS atlas feature and artifact agreement

  Through study completion (up to 24 months)

Study Arms (1)

Children undergoing clinically indicated head CT for suspected ABI in the pediatric ED and PICU

Combined ED + PICU sampling enriches for CT-positive cases and supplies the serial-imaging subset.

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children undergoing a clinically indicated head CT for suspected acute brain injury in the pediatric Emergency Department and Pediatric Intensive Care Unit at the Children's Hospital of Richmond at VCU. Combined ED + PICU sampling enriches the cohort for CT-positive cases and provides the CT-positive subset with serial paired imaging.

You may qualify if:

• Children 2 to 17 years of age
• Undergoing a clinically indicated (standard-of-care) head CT for suspected acute brain injury (including trauma, headache with neurologic findings, altered mental status, focal deficit, seizure, post-cardiac-arrest, oncologic neurologic emergency, or intracranial infection)
• Seen in the pediatric Emergency Department or Pediatric Intensive Care Unit at the Children's Hospital of Richmond at VCU (CHoR-VCU)
• Consent obtainable from a legally authorized representative (LAR)
• Cranial ultrasound feasible within the protocol time window (within 6 hours of head CT)

You may not qualify if:

• Open skull fracture
• Prior hemicraniectomy
• Cranial surgical defect at the insonation site
• Anticipated transition to comfort-only care
• Any clinical condition in which cranial ultrasound would delay a time-critical intervention

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• UMass Chan Medical School: collaborator
• Atrium Health Levine Children's Hospital: collaborator
• Children's Hospital of Richmond at VCU: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic; Intracranial Hemorrhages; Hydrocephalus; Stroke; Brain Neoplasms; Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Ischemia; Hypoxia, Brain; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Aarti Sarwal, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Alia Marie O'Meara, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aarti Sarwal, MD

CONTACT

804-828-9499; aarti.sarwal@vcuhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 19, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)